Phase I study of CMV specific CTL for treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation

UMIN ID: UMIN000001749

Registered date:03/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Refractory CMV infection after allogeneic hematopoietic stem cell transplantation
• Date of first enrollment: 2009/03/01
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Administration of CMV specific CTL induced and expanded from donor peripheral blood

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Monitoring of CMV reactivation (quantitative PCR and CMV antigenemia) and CMV specific CTL in peripheral blood

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Severe or uncontrollable bacterial, fungal, and viral (except CMV) infection 2. Uncontrollable acute and chronic GVHD 3. Psychoses 4. History of allergic reaction to albumin

Related Information

• Primary Sponsor: Department of Pediatrics, Nagoya University Graduate School of Medicine
• Secondary Sponsor: Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
• Source(s) of Monetary Support: Department of Pediatrics, Nagoya University Graduate School of Medicine